Sanofi Group Program / Project Lead - Commissioning, Qualification, and Validation in Framingham, Massachusetts
*Monday-Friday- 1st shift*
*Onsite position with flexibility to work remote when appropriate*
*Fast-paced manufacturing environment*
*Managing a team of external contractors*
The Framingham Engineering, Projects & Controls organization is responsible for providing Engineering support to organizations on the Framingham campus. This organization is comprised of 3 groups: Engineering, Commissioning and Qualification and Projects and Controls.
The Framingham Engineering, Projects & Controls organization will be supporting the following groups at the Framingham campus: (1) Framingham Biologics - comprised of commercial Fabrazyme, Thyrogen and Global Cell Banking operations. (2) Framingham Facilities Operations - responsible for campus wide facilities and utilities operations per established Service Level Agreements and (3) Framingham Campus - in the context of programs/projects requiring approval, planning and execution across the Sanofi groups on the Framingham campus. While each business has its own Engineering support group, the Framingham Engineering, Projects and Controls organization will interact with all of these groups on projects/programs with campus impact.
This organization is responsible for providing Engineering support for all cGMP process and utility systems at Framingham Biologics, maintaining these systems in a validated state of control and ensuring uninterrupted business continuity. This organization is also responsible for shared GMP systems on the Framingham campus as defined by Service Level Agreements. The Capital Projects group is responsible for the planning and execution of projects and programs under its scope as determined by budget and other pre-established criteria, ensuring projects/programs are completed to established schedules and budget. The Commissioning and Qualification groups will be responsible for providing C&Q support to systems and projects/programs within the scope of this organization.
Responsible for commissioning, qualification and validation activities related to one or more of the following areas: FAT, SAT, DQ, IV, OV, IQ, OQ, PQ, and requalification activities for facilities, utilities, equipment, cleaning, and sterilization.
60% - CQV project leadership
Perform validation in a GMP biotech manufacturing facility managing multiple medium to large size validation projects and providing technical assistance to less experienced technicians/engineers.
Develop Validation plans for medium to large size validation projects and oversee contract staff, when necessary, including developing statement of work and vendor selection.
Write, review and approve commissioning, qualification and validation protocols and reports as well as execute protocols. Resolve protocol discrepancies and deviations.
Perform change control assessment 30% CQV Program Ownership
Lead department continuous improvement initiatives
Own and maintain the validation program quality systems
Establish, generate, and maintain validation department procedures in compliance with corporate and industry standards.
Lead gap analyses and participate in risk assessments
Generate, review and approve deviations, CAPAs, perform/lead investigations and root cause analysis. 10% CQV Inspection Lead
Present and defend validation studies during regulatory inspections and internal audits.
Serve as primary point of contact for audit requests Leadership Qualifications An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
- Sanofi's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.
Leading the Business
- Sanofi's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.
Delivering to Customers
- Sanofi's leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.
Bachelor’s degree in engineering/science and 8+ years of relevant experience (e.g., engineering or quality role in a regulated environment, preferably GMP) or Master’s degree in engineering /science and 6+ years of relevant experience or equivalent combination of experience and training.
Strong interpersonal, organizational, and technical skills.
Capability to work both independently and in a team environment.
Strong analytical and communication skills are required.
Capable of leading teams to deliver results, including project management and KPI reporting
Excellent written and verbal presentation skills to support interactions with senior leadership and inspectors.
Familiarity with applicable US and worldwide regulatory requirements.
Ability to read/interpret engineering drawings and design documents.
Management of medium to large size projects.
Excellent technical writing and verbal communication skills.
Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
Knowledge of Validation Lifecycle Approach.
Strong mentoring and development experience are required.
Must be able to establish strong working relationships with stakeholders (Quality, Manufacturing and MSIT) to ensure high quality deliverables meeting CGMP and site quality requirements. Development of project execution plans for medium to large size projects.
Understanding of Validation using risk-based approach
Demonstrated success working across organizations in highly cross-functional team environment.
SPECIAL WORKING CONDITIONS:
Requires some off-shift availability when necessary (typically 10-20% of the time) potentially including weekends and holidays.
Ability to lift 20 lbs.
Ability to gown.
Ability to gain entry to confined space.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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